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NCT02637609 · ClinicalTrials.gov registry record
Measuring the Priorities of Patients With Type II Diabetes Using Likert Scale and Best-worst Scaling
A clinical trial, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- 1,103
- Enrollment target
NCT02637609 is a clinical trial that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 1,103 participants.
The verdict
NCT02637609 has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- 1,103 participants
- Enrollment target
Study Summary
In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. In addition to a detailed description of benefits and risks, CDRH listed "patient tolerance for risk and perspective on benefit" as a factor that CDRH may consider in regulatory reviews. It underlined the need for developing methods to measure patient preference and incorporate it into regulatory decision-making. The purpose of this study is to advance methods for patient and community engagement in patient-centered outcome research (PCOR) and has three objectives. First, demonstrate good practices for patient and community involvement in PCOR projects by applying principles of community-based participatory research (CBPR). Second, address methodological gaps pertaining to the use of stated-preference methods in studying priorities in PCOR. These include identifying the best methods for identifying patient priorities and strategies for analyzing variation in priorities. The investigators also seek to assess the relevance of stated-preference methods to patients and stakeholders using both qualitative and quantitative methods. Third, demonstrate good practices for applying stated-preference methods by studying the priorities of patients with type II diabetes. While type II diabetes provides an important case study, this research will advance approaches and methods that will be broadly generalizable to other diseases, and to diverse patient and stakeholder groups. Clinical Significance: This project will illustrate and advance methods for assessing the values of patients and stakeholders. It will demonstrate how CBPR methods apply to PCOR studies and the value of stated-preference methods in measuring the priorities of patients and stakeholders and directing health care.
Interventions
- OTHER Likert Scale
- OTHER Best-Worst Scaling (Case 1)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,103 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02637609
The ClinicalTrials.gov registry entry for NCT02637609 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 1,103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Likert Scale is the first listed.
NCT02637609 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02637609 about?
NCT02637609 is a clinical study titled "Measuring the Priorities of Patients With Type II Diabetes Using Likert Scale and Best-worst Scaling". In 2012, the FDA Center for Devices and Radiological Health (CDRH) issued guidance to clarify the principal benefit-risk factors FDA considers during the reviews for premarket approval applications and de novo classification requests. In addition to a detailed description of benefits and risks, CDRH...
What is the current status of trial NCT02637609?
This trial is currently completed. The enrollment target is 1,103 participants. The study started on 2013-07. Estimated completion is 2017-02.
What interventions are being tested in trial NCT02637609?
The interventions under investigation include: Likert Scale (OTHER), Best-Worst Scaling (Case 1) (OTHER).
Who is sponsoring clinical trial NCT02637609?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
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